Paclitaxel Poliglumex (CT-2103) vs. Paclitaxel for the Treatment of Women With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) Who Are Performance Status 2.

TerminadoFase 3ClinicalTrials.gov

ID: NCT00269828Tipo: INTERVENTIONALInicio: 1 de dic de 2005Fin estimado: 1 de dic de 2006

Traducción no disponible, mostrando original

Resumen

This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2. Study drug will be administered on day 1 of each 21 day cycle

Descripción detallada

See Summary

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Adequate renal function
Adequate hepatic function
Female.
Histologically- or cytologically-confirmed diagnosis of NSCLC.
ECOG performance score of 2.
Patients who meet one of the following criteria:
Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or
Stage IV.
Age greater than or equal to 18 years.
Adequate bone marrow function
Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site's institutional standards.
Patients who have had major surgery must be fully recovered from the surgery.
Ability to comply with the visit schedule and assessments required by the protocol.
For patients of reproductive potential, commitment to use adequate contraception.
Signed approved informed consent, with understanding of study procedures.
Agreement to begin study therapy within 8 calendar days after randomization.
Clinically significant active infection for which active therapy is underway.
Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable.
Pregnant women or nursing mothers.
Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Criterios de exclusión

Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103).
Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
Grade 2 or greater neuropathy.

Intervenciones

drug

paclitaxel

drug

paclitaxel poliglumex

Ubicaciones

Sanatorio Parque

Rosario, Santa Fe Province, Argentina

CETEN

Beunos Aires, Argentina

Hospital Privado de Comunidad

Buenos Aires, Argentina

Hospital General de Agudos "Dr Teodoro Alvarez"

Buenos Aires, Argentina

Instituto Alexander Fleming

Ciudad de Buenos Aires, Argentina

Instituto Oncologico de Cordoba - IONC

Córdoba, Argentina

LUCEN

Cuidad Autonoma de Buenos Aires, Argentina

ISIS Clinica Especializada

Urquiza, Argentina

Patrocinadores

PrincipalCTI BioPharma

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